Tissue opening occluder

ABSTRACT

A tissue opening occluder comprising first and second occluder portions, each occluder portion including a frame structure and an attachment structure to attach one portion to the other portion. The frames may be utilized to constrain the tissue between the two portions enough to restrict the significant passage of blood therethrough. The frame portions may be covered by a fabric suspended from a perimeter thereof. The occluder portions are conjoined at least one point on each portion.

[0001] This is a regular application filed under 35 U.S.C. §111(a)claiming priority under 35 U.S.C. §119(e)(1), of provisional applicationSerial Nos. 60/309,337, 60/309,376, and 60/309,418, all having a filingdate of Aug. 1, 2001, all of which were filed pursuant to 35 U.S.C.§111(b).

TECHNICAL FIELD

[0002] The present invention generally relates to devices for occludinga tissue opening such as a patent foramen ovale (PFO) or shunt in theheart, the vascular system, etc. and particularly provides an occluderdevice deliverable via a catheter to the site of a tissue opening.

BACKGROUND OF INVENTION

[0003] The device of the subject invention, in all its embodiments, maybe utilized for the occlusion of many types of tissue openings, such asseptal defects and PFO, and the like. For the sake of clarity, thepresent invention may, at times, be described specifically in thecontext of occlusion of a PFO. This specific description, however,should not be taken to limit the scope of the possible applications ofthe present invention.

[0004] The term “patent foramen ovale” generally refers to the failureto close a normal opening between the left and right atria (i.e., upperchambers) of the heart. Typically, a foramen ovale is a flap-likeopening between the left and right atria of the heart which persistslong after birth. Commonly, the foramen ovale has one flap extendingfrom the top of the atrial chamber and another flap extending from thebottom of the atrial chamber, wherein the two flaps meet or overlap eachother. Specifically, a PFO is typically located between the atrialseptum primum and secundum at the location of the fossa ovalis. Theopening provides a path to allow blood to bypass the lungs in an unborninfant, since the lungs are not in use during that period. The foramenovale typically becomes functionally closed after the birth of theinfant due to greater pressure from the increased blood flow in the leftatrium acting upon the flap. However, in humans, for example, as many as1 in 5 people have foramen ovale that do not fully close. In the absenceof other cardiac defects or unusual cardiac pressures, the open foramenovale does not present a substantial problem. However, in patientshaving circulatory problems wherein the pressure on the right side ofthe heart is increased, for example as the result of congenital heartdisease, blood may begin to flow through the foramen ovale. This resultmay also occur, for example, in divers when experiencing an increase inpressure due to being under water. The presence of a significantly largePFO, a flap structure that cannot provide sufficient seal, or asignificant increase in pressure can cause blood to shunt across thedefect from the right atrium to the left atrium and hence on to the leftventricle, aorta, and brain. If the defect is not closed, the risk ofstroke is increased. Shunting of blood from the left to the right sidecan also have negative consequences, such as cardiac failure orhemoptysis.

[0005] Tissue openings have traditionally been corrected by open heartsurgery which required the surgeon to open the chest of a patient andbypass the heart temporarily. The surgeon would then physically cut intothe heart and suture the opening closed. In the case of larger defects,a patch of a biologically compatible material would be sewn onto thetissue to cover the opening. However, the risk of complicationsoccurring during such an intricate procedure presents substantialproblems that patients would rather avoid.

[0006] In order to avoid such complications and the long recovery timesassociated with open heart surgery, a variety of trans-catheter closuretechniques have been implemented. In such techniques, an occludingdevice is delivered through a catheter to the site of the tissueopening. Once the occlusion device is positioned adjacent the opening,it must be attached to the tissue wall containing the opening in amanner that permits it to effectively block the passage of blood throughthe opening. Furthermore, the occlusion device must also adjust to theanatomy or structure of the PFO, commonly a tunnel like structure, thewidth and length of which varies substantially between patients. As hasbeen documented in the literature, the trans-catheter techniquesdeveloped thus far have had drawbacks associated therewith.

[0007] For example, a variety of heretofore known devices requireassembly at the situs of the tissue opening. That is to say separable orseparate halves of the device are deployed and subsequently united so asto traverse or span the tissue opening in furtherance of closure. Somewell known devices require threading or “buttoning” of the discretedevice elements. Additionally, such devices require special deliveryand/or deployment tools, making their utility less than desirable.

[0008] A further shortcoming in the art yet to be adequately and fullyaddressed is the issue of device positioning at the situs and, moreparticularly, re-positioning in furtherance of effectuating a properseal of the tissue opening. Also not addressed is the ability toretrieve the device from the situs without damage thereto. Heretofore,known devices appear to evidence a broad functionality, namely that ofocclusion, or more pointedly, plugging a tissue opening without a fullor more developed functionality of the constituents or substructures ofthe device, e.g., a device which includes a single occluder reversiblysecured in place by an anchor assembly.

[0009] Heretofore known self expanding devices tend to be structurallycomplex, expensive to produce and cumbersome to load, unload, andreliably position at the situs of a tissue opening, and insensitive tothe variable requirements of the PFO tunnel geometry. The balance ortension between the structural integrity of the device, its “size”(e.g., bulk, rigidity, etc.), and ability to remain optimally positionedcontinues to be a critical consideration, cardiac devices being subjectto the rhythmic pumping of the heart, on the order of 100,000 beats perday.

[0010] The present invention addresses the needs of the field, as wellas other problems associated with the prior art. The present inventionoffers advantages over the prior art and solves problems associatedtherewith.

SUMMARY OF THE INVENTION

[0011] The present invention is a tissue opening occluder whichpreferably has first and second portions. Both portions include a frame.One or both of the portions may have means for attaching the twoportions together. Each of the frame portions is placed or positioned onone of opposite sides of a tissue wall to occlude the opening enough torestrict the significant passage of blood therethrough. One or both ofthe frame portions may also have a fabric support structure and havefabric suspended from a perimeter thereof. The fabric preferably is ofsuch a type that it promotes the growth of tissue on the surface of orwithin the fabric. The portions may be directly attached together,attached by means of an attachment structure that is independent ofeither portion, may be conjoined at a single point or at a plurality ofpoints, or may be attached by their frame and/or fabric elements. One orboth of the portions may be formed in different shapes or may beidentically configured.

[0012] In a first embodiment of the subject invention, the portions orhalves of the occlusion device are configured as occluding panels,namely reversibly expandable elements which cooperatively engageopposing wall portions in the vicinity of the tissue defect (e.g.,structures which are positioned in each atrium). Such occluding panelsmay be substantially planar or may have a significant third dimension. Avariety of linkages are contemplated for integrating or otherwisejoining the panels such that the sought after device responsiveness isobtained.

[0013] In a first alternate embodiment of the subject invention, onehalf of the occlusion device may be configured as an occluding panel(i.e., atrium engaging element), having two or three dimensions, whilethe second half may comprise a planar wire anchor structure which isconfigured to resiliently occupy a body structure, such as a PFO“tunnel,” in furtherance of stabilizing the occluder panel portion ofthe device. The anchoring or positioning member may utilize one or morehook structures for engaging tissue surrounding the opening.

[0014] In yet a further embodiment of the subject invention, the deviceis adapted to be received and retained exclusively within the PFO“tunnel,” no structure thereof extending into the atrium. The anchorstructure stabilizes an occluding panel such that the panel “bridges”the portions of the septum within the area of the defect.

[0015] The present invention is thus an improved device over structuresknown in the prior art. More specific features and advantages obtainedin view of those features will become apparent with reference to thedrawing figures and DETAILED DESCRIPTION OF THE INVENTION.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016]FIGS. 1 and 2 are side views of tissue opening occluders of thepresent invention, particularly illustrating the cooperative engagementof a pair of occluder panels;

[0017] FIGS. 3-9 illustrate a representative variety of operativeengagements contemplated for the structures of the present invention;

[0018]FIG. 10 illustrates a side view of an anchored occluder of thesubject invention sealing a PFO;

[0019]FIG. 10A is a plan view of the device of FIG. 10;

[0020]FIG. 11 illustrates the anchor structure of FIG. 10A;

[0021] FIGS. 12-23 illustrate alternate embodiments of the device ofFIG. 10, FIG. 13 illustrating only the anchor portion of the device incombination with linkage structure;

[0022]FIG. 24 illustrates yet a further embodiment of the tissue openingoccluder of the present invention, in side view, in a deployedcondition; and, FIGS. 25-26 illustrate embodiments of the occluder panelof FIG. 24.

DETAILED DESCRIPTION OF THE INVENTION

[0023] As a preliminary matter, the subject invention contemplates threegeneral configurations, several styles of each shown and subsequentlydescribed in the figures. The first general configuration for the tissueopening occluder (e.g., those illustrated in FIGS. 1-9) is characterizedby paired occluder panels which are operatively joined so as to permit ahigh degree of motion, including rotation. The occluder panels arepositioned within each atrium so as to “patch” (i.e., overlay) theseptum in the vicinity of the defect, each occluder panel being inrelative tension (i.e., being drawn towards each other). The secondgeneral configuration for the tissue opening occluder (e.g., thatstructure illustrated in FIGS. 10-23) is characterized by a singleoccluder panel, functioning in a similar capacity as heretoforedescribed, anchored by a substantially planar wire structurepositionable for retention within the “tunnel” of the PFO (i.e.,overlapping septal portions). A third configuration for the tissueopening occluder (e.g., those illustrated in FIGS. 24-26) ischaracterized by its deployed, occluding position, specifically itsretention within a defect such that the device is effectively containedwithin a tunnel of a PFO so as to greatly reduce, if not eliminate,passage (i.e., shunting) of blood from the right to left atrium.Finally, a variety of advantageous linkages, namely those of FIGS. 3-9,facilitating operative engagement between the major structural elementsof the several embodiments, are provided.

[0024] Referring generally to FIGS. 1 and 2, there is illustrated afirst general configuration for the subject reversibly deployable tissueopening occluder 30 which includes first and second portions, moreparticularly, an occluder panel 32 and an anchor assembly 34 extendingtherefrom, each of these structures being intended to be opposinglypaired about a tissue opening of a type as illustrated in FIG. 10. Theanchor assembly 34 of this general configuration comprises a panelsimilar to the occluder panel, however not necessarily identicaltherewith, which is joined, at least indirectly, to the occluder panel32 via a linkage 44. The occluder panel 32 includes a fabric supportstructure 36 and fabric 38 supported by a perimeter thereof. The fabricsupport structure may include the wire frame, the linkage, or both. Thewire frame can be of many shapes and is preferably made of superelasticwire, preferably Nitinol. The wire frames preferably have apredetermined shape which is restored after deployment of the wire framethrough a delivery catheter. The fabric is secured to the fabric supportstructure by suturing or other methods known in the art. The fabric isbiocompatible and preferably supports tissue ingrowth so as to stabilizethe implanted device at the implant site. Suitable fabrics includepolyester, ePTFE, and other appropriate materials. Preferably, but notnecessarily, the occluder panel 32 may embrace the panel stylesdisclosed in pending U.S. patent applications Ser. No. 09/628,211 andSer. No. 09/760,056, and in issued U.S. Pat. No. 6,214,029, each ofwhich are incorporated herein by reference. As will be later detailed,once the occluder panel 32 is reliably positioned relative to the septalwall (e.g., within the left atrium), it may be anchored to the tissuewall via the anchor assembly 34 (i.e., positioning and deployment of theproximal anchor in abutting engagement with the septum within the rightatrium), thereby eliminating the flow or shunting of blood through theopening or passageway.

[0025] Referring now to FIGS. 3-9, a variety of linkages 44 areillustrated for the occluder panel/anchor assembly. Each of thesestructures provide resilient directional translation and rotation forone half of the device with respect to the other. The key considerationis the responsiveness of the occluder panel 32 with and to, the anchorassembly 34 during engagement of the occluder panel 32 with the tissueopening.

[0026] The linkage 44 may take the form of extra winds on conjointeyelets 46 (FIG. 3) and the eyelets may be enlarged. The linkage mayinclude one or more fibers of material such as a suture or wire (FIGS.4-9). The suture may be a wire suture and may be made of Nitinol. Thelinkage 44 may more particularly include a wire structure such as aloop, coil, or spring, such as a coil spring or a leaf spring. Thelinkage 44 may have opposing ends terminating in loops or eyelets tofacilitate connection to each of the halves of the device. Furthermore,greater than one linkage may be provided between the occluder panel 32and the anchor assembly 34 (FIG. 7, see also FIG. 1 in which the anchorassembly is configured similarly to the occluder panel).

[0027] Referring now to FIGS. 10 and 10A, an alternate configuration ofthe tissue opening occlusion device 30 of the subject invention isillustrated in a fully deployed condition, fully engaged with portionsof a tissue wall adjacent an opening or passage therethrough, (e.g.,foramen ovale) so as to effectively block blood flow through thepassage. The reversibly deployable tissue opening occluder 30 generallyincludes first and second halves, more particularly, an occluder panel32 and an anchor assembly 34 extending therefrom. The occluder panel 32includes a fabric support structure 36 and fabric 38 (not shown in FIGS.10 and 10A) supported by a perimeter thereof. Preferably, but notnecessarily, the occluder panel 32 may embrace the panel stylespreviously noted. As will be later detailed, once the occluder panel 32is reliably positioned relative to the septal wall, it may be anchoredto, or at least relative to, the tissue wall via the anchor assembly 34,thereby eliminating the flow or shunting of blood through the opening orpassageway.

[0028] The anchor assembly 34 of FIGS. 10-23 generally includes a wireanchor element 40 of generally planar configuration adapted to beselectively manipulatable in furtherance of positioning and securing theoccluder panel 32 at a tissue opening situs. The wire anchor element 40,as shown, is intended to be positioned and retained within acharacteristic “tunnel” of the PFO, as for instance by expansion of thestructure into tensioned engagement with portions of the tunnel. Thewire anchor element 40, as will be later discussed in detail, is atleast indirectly linked to a central portion 42 of the fabric supportstructure 36, the occluder panel 32 and anchor assembly 34 being therebyopposingly urged into engagement with the tissue opening in furtheranceof closure of the tissue opening or passage. As will become evident, itis preferred that the wire anchor element 40 have a portion configuredto snugly fit against a portion of the tissue wall, and that at least aportion of the wire anchor element 40 be wide enough to anchor or setthe occluder panel 32 in place despite the forces being applied to thedevice generally by the fluid running through the structure (e.g.,heart, vessel, etc.) in which the device is placed. It is to be furtherunderstood that the wire anchor element 40 may itself be a fabricsupport structure (i.e., function to suspend fabric from at least aperimeter thereof), to the extent that the addition or inclusion offabric is advantageous in furtherance of “setting,” in a long termsense, the anchoring assembly (i.e., pseudo-assimilation of thestructure to the tissue: further adherence of the structure to thetissue) post device deployment, or advantageous in immediate closure ofthe passage such as by clotting.

[0029] The anchor assembly 34 of the tissue opening occluder 30 furtherincludes linkage 44 (not shown in FIGS. 10 and 10A) which joins the wireanchor element 40 to or with the occluder panel 32. This linkage 44 maybe integral to the wire anchor element 40, as illustrated for instancein FIGS. 10 and 11, or may be a separate, discrete structure, see forinstance FIG. 15, which is interposed between the wire anchor element 40and the occluder panel 32. Generally, the functionality of the linkageis to permit a resilient multi-directional (i.e., in the Cartesiancoordinate sense, namely the x, y, z directional senses) spacing of thedevice portions. It is advantageous that the wire anchor element 40possess a high degree of freedom with respect to its motion relative tothe occluder panel 32. In addition to the aforementioned x, y, and zmotion, the ability to account for rotation (i.e., torsion) isdesirable. It is preferable that the linkage be capable of reversibleelongation. The occluder portions 32, 34 may be attached at a singlepoint preferably at or near the center of the occluder panel 32, or,alternatively, conjoined at a plurality of discrete points, located orpositioned within the bounds or adjacent the perimeter of each of thehalves 32, 34 (i.e., within an area bounded by each perimeter of thephysical structures 32, 34), or on the fabric 38 as applicationswarrant.

[0030] As an integral component of the wire anchor element 40, thelinkage 44, more particularly the physical point of connection of theoccluder panel 32 to the wire anchor element 40, is preferably an eyelet46 (i.e., a loop) as shown in FIGS. 1 and 2. Similarly, the centralportion 42 of the fabric support structure 36 of the occluder panel 32preferably includes eyelet 46, or a plurality of eyelets, for engagingthe linkage 44 of the anchor assembly 34. It is to be understood that asused herein, the term “eyelet” refers generally and broadly to a loopwithout limitation (e.g., round, elongate, angular, single, multiple(i.e., coil), etc.). In addition to convenient connection means, theeyelets impart a further resiliency or spring-like quality to thestructures into which they are incorporated, thereby fortifying thecooperative action of the anchor assembly with the occluder panel.

[0031] As is appreciated with reference to the figures, the planar wireanchor element 40 preferably, but not necessarily, has a periphery thatextends out into the atria when positioned in furtherance of deviceanchoring. More particularly, the wire anchor element 40 is orientedsubstantially parallel to the tissue wall. The anchor profile should below so that tissue can grow into the implant and so that the implantdoes not cause flow disturbance or facilitate clot formation. It ispreferred in these embodiments, that the angle of difference between thetissue wall and the wire anchor element be less than 45 degrees, butmore preferably may be less than 15 degrees. This angle of difference ispreferably measured from the central axis of the tissue wall.

[0032] Anchor shapes are provided which offer capability to conform tothe geometry of a PFO tunnel and resistance to inadvertent ejection fromthe tunnel in the direction of the occluder panel. The PFO tunnelgenerally ranges from 3-10 mm in width and 1-20 mm in length and isgenerally flat in height with no thickness under “at rest” conditions.Anchors such as those shown in FIGS. 12, 14, 16, 17, 21 and 22 offersuperior ability to conform to different or variable tunnel widths.Further, the generally planar geometry of anchors shown in FIGS. 12-23conform to the generally planar geometry of the PFO tunnel. Further,anchors such as those shown in FIGS. 14, 15, 17, 19 and 21 offersuperior resistance to ejection from the PFO tunnel once fully orpartially deployed in the tunnel due to a portion of the anchor framebeing substantially parallel to the occluder panel (as shown in thefigures). Finally, designs such as the anchor in FIGS. 17 and 21 providesuperior accommodation of variable PFO tunnel lengths while maintaininga frame edge that, when deployed, will resist ejection from the tunnelIt is further advantageous, however not necessary, that the anchorassembly 34, more particularly the wire anchor element 40, include oneor more hooks 48 (e.g., FIGS. 16/16A) for attachment of the anchorassembly 34 to the tissue wall. In devices so equipped, the portion ofthe wire anchor element 40 having the hook or hooks 48 formed therein,or extending therefrom, will extend substantially parallel to the tissuewall. The one or more hooks may be formed, carried and/or arranged on orwith respect to the wire anchor element 40 in any suitable manner knownin the art. For example, as shown in FIGS. 16/16A, the wire anchorelement 40 is formed having a hook 48 on an end opposite the attachmentpoint of the two halves 32, 34. In this case, substantially the entirewire anchor element 40 will be generally aligned along the surface ofthe tissue wall (i.e., in conformity therewith) when the hook 48 thereofis engaged in the wall.

[0033] As previously noted, the occluder panel 32 comprises a fabricsupport structure 36 and fabric 38 supported or suspended by a perimeterthereof. The fabric support structure 36 of the occluder panel 32 isgenerally flexible and elastically deformable. Fabric 38, which may beformed of a thin, flexible material which can be folded and pulled tautwithout being damaged, is suspended or otherwise affixed to theperimeter of the fabric support structures 36. It may be desirable toprovide an excess of fabric to the panel 32 or the anchor 40 so as tofacilitate collapse of the fabric carrying structure into a catheter.

[0034] The fabric 38 is preferably a relatively porous material. Whilethis may seem to contradict the purpose of the device, blood will tendto coagulate on the latticework provided by the porous material. Bloodflow across the tissue opening is usually substantially blocked afterminimal time passage. If so desired, the fabric 38 of the occluder panel32 may be treated with a thrombogenic agent to speed this naturalprocess, or may be impregnated with a biocompatible polymeric compoundor the like to make it relatively impervious to fluids.

[0035] The primary purpose of using a porous fabric is to accelerate theprocess of permanently anchoring the device in place. The supportstructures hold the fabric tautly and in intimate contact with thesurface of the tissue wall. This intimate contact between the tissuewall and perimeter of the occluder permits ingrowth of collagen andfibrous tissue from the tissue wall into the fabric. Over time, themembrane resting against the tissue wall will become securely anchoredto the wall and be covered by a layer of endothelial cells. Elasticpolymeric materials such as, for example, polyester knit, nylon,polypropylene, polytetrafluoroethylene (e.g., Teflon®), and expandedpolytetrafluoroethylene (e.g., GoreTex®), as well as natural fabricssuch as silk, are suitable materials for covering the fabric supportstructure 36 of the occluder panel 32.

[0036] To accommodate the need of the fabric support structure 36 todistort when retrieving the device 30 into a catheter, excess fabric canbe provided. On an area basis relative to the support structure, anexcess of fabric in the range, typically, of about 30-35 percent, and upto 50 percent, is sufficient. This range is required because the lowstretch characteristics of the fabric prevent the support structure fromcollapsing in a manner suitable to get into the catheter. However, a 30denier polyester knit is advantageous in that it possesses a low stretchcharacter, is approximately 50% less bulky than known jersey style knitpatterns which facilitates the use of smaller delivery catheters, andallows for the device of the subject invention to be retrieved into suchcatheters at forces that are not detrimental to either the catheter orthe device (e.g., a 40 mm occluder may be pulled into a 12 Frenchcatheter using a reasonable peak force of about four pounds).

[0037] The fabric 38 may be attached to support structures 36, or wireanchor element 40 as the case may be, by any suitable means. Forinstance, the fabric 38 may be directly attached to the supportstructures 36 by means of an adhesive or the like, or the periphery ofthe fabric 38 may be wrapped about the support structures 36 and theperipheral edge attached to the rest of the fabric so as to essentiallydefine a sleeve about the support structures 36. In the latter instance,the sleeve may fit the support structure relatively loosely so that thestructure may move within the sleeve with respect to the fabric. Theperipheral edge of the fabric may be affixed to the rest of the fabricsheet 38 in any suitable fashion such as by sewing. Preferably, though,the periphery of the fabric can be sewn to at least some portion of theperimeter segments of the support structures 36 using a polyester,non-adsorbable suture or the like.

[0038] The planar wire anchor element 40 and the fabric supportstructure 36 are preferably formed of a flexible, elastically deformablematerial such as a biocompatible metal, metal alloy or polymer, mostpreferably a superelastic material. One such material currently known inthe art is a near-stoichiometric nickel/titanium alloy, commonlyreferred to as Nitinol or NiTi. Such superelastic materials may beelastically deformed to a much greater extent than most other materials,yet substantially fully recover their original shape when released. Thispermits the frame to be deformed sufficiently for insertion into, andpassage through, a small-diameter catheter, yet automaticallyelastically return to its initial shape upon exiting the catheter.

[0039] The frame portions are preferably manufactured with nitinol wirethat can be wound around the pins of a forming die and subjected to heattreatment. The wire may be bent through greater than 360 degrees to formthe loops or eyelets. The ends of the wire may be attached to each otherin any secure fashion, such as by means of welding, a suitablebiocompatible cementitious material, or by any means known in the art.For example, the wire ends of each frame half can be connected with atitanium hypo tube using a compression crimp. Titanium is more ductilethan nitinol, providing a reliable grip with excellent corrosionresistance, thereby making this method suitable for joining the ends ofthe material. Alternately, the preferred forms for the fabric supportand/or the wire anchor element may be cut out from a sheet of suchsuperelastic material as a single structure, by chemical etching,punching with a suitable punch and die, or any other appropriate formingmethod.

[0040] In order to enhance radiopacity so that the device can be viewedremotely during deployment, either the fabric support structure 36 orthe wire anchor element (or both) may be provided with a radiopaquecoating, such as gold or platinum. For instance, the wire may be platedwith a thin layer of gold or platinum. For instance, a helically woundlength of a thin radiopaque wire may be placed over the wire,alternatively, radiopaque marking bands, which are commerciallyavailable, may be employed. By placing one such band on segments ofdevice structures, a physician can remotely visualize the frame as aplurality of small bands; when the bands are appropriately spaced fromone another on a monitor, the physician knows that the frame is properlydeployed. Alternatively, the fabric support structures can be made ofwire with a radiopaque core.

[0041] With general reference to FIGS. 12-23, alternate embodiments ofthe tissue opening occluder 30 of the subject invention are illustrated,more particularly numerous configurations for the anchor assemblies 34(e.g., the planar wire anchor elements 40): an “eye” (FIGS. 12 and 13);“mushroom heads” (FIGS. 14, 15, 16, and 18); lobed elements (FIGS.19-21); and the styles which are the subject of FIGS. 1, 2, 17, 22 and23. The embodiments of FIGS. 15-18 show a discrete linkage 44 interposedbetween the occluder panel 32 and the anchor assembly 34 so as to definea non-stressed spaced apart condition for said structures.

[0042] FIGS. 24-26 illustrate a further embodiment of the tissue openingoccluder of the present invention in a deployed configuration. FIGS. 25and 26 illustrate the construction of the occluder panel 32. The panel32 includes a fabric support structure 36 which is shown as having aplurality of eyelets 46 formed therein. A fabric swatch 38 is mounted tothe fabric support structure 36 in an appropriate manner such as bymeans of suturing (not shown).

[0043]FIGS. 25 and 26 illustrate an anchor element 40. As discussedgenerally herein with regard to all embodiments, upon the occluder panel32 being deployed into position within the PFO infudibulum, the anchorelement 40 can be allowed to spring into an expanded configuration inwhich it operatively functions to hold the occluder panel 32 in positionwithin the infudibulum.

[0044] The anchor element 40 of FIGS. 24-26 is a generally straight wiresegment which, when to be deployed from, for example, a catheter (notshown) , springs to its operational configuration at least in secureengagement with heart tissue. In some instances, however, the anchorelement 40 would spring into, and pass through, the heart tissue. Thatis the disposition illustrated in FIG. 24.

[0045] It will be understood that the fabric support structure can, insome embodiments, comprise a single continuous wire made of nitinol. Astructure employing multiple nitinol sections, however, can also beutilized.

[0046] The swatch of fabric is made of any appropriate materialdiscussed hereinbefore. In any case, the material of which it is madewill function to promote tissue growth within the PFO infudibulum.

[0047] It will be understood that insertion of the occluder panel 32into the PFO infudibulum will be accomplished in a manner known in theprior art. Typically, a nitinol fabric support structure would bepositioned within a deployment catheter in a contracted configuration.After the catheter has been inserted through a patient's vasculature toarrive at the PFO, it can be deployed in an appropriate manner known inthe prior art. Appropriate deployment techniques are taught in pendingU.S. patent application Ser. No. 09/628,211, application Ser. No.09/760,056 and issued U.S. Pat. No. 6,214,029. Those techniques arehereby incorporated by reference.

[0048] Although the foregoing has focused on application of the presentinvention to occlude atrial PFO, the invention is not limited tooccluding only foramen ovale. For instance, the instant occlusion devicecan be used to treat atrial septal defect, ventricular septal defect,patent ductus arteriosus, or any other congenital or acquired orificialor tubular communications between vascular chambers or vessels.

[0049] While a preferred embodiment of the present invention has beendescribed, it should be understood that various changes, adaptations andmodifications may be made therein without departing from the spirit ofthe invention. Changes may be made in details, particularly in mattersof shape, size, material, and arrangement of parts without exceeding thescope of the invention. Accordingly, the scope of the invention is asdefined in the language of the appended claims.

What is claimed is:
 1. An occluder for placement through an opening in atissue wall comprising first and second occluder portions, each occluderportion including a frame structure having a perimeter, and anattachment structure for attachment of one of said portions to the otherof said portions, said occluder portions being attached at at least onediscrete point on each portion, said attachment structure between saidfirst and second occluder portions being configured and disposed toconstrain a portion of the tissue wall between said portions.
 2. Theoccluder of claim 1, wherein at least one of said frame structures hasfabric suspended from the perimeter of said frame structure.
 3. Theoccluder of claim 1, wherein at least one of said frame structures isoriented, when in position adjacent a tissue wall, such that a planedefined by the frame structure is substantially parallel to said tissuewall.
 4. The occluder of claim 3, wherein at least one conjoined pointwithin both of said frame structures is defined by a loop formed in saidframe structures.
 5. The occluder of claim 1, wherein one of said frameshas a hook formed thereon for attachment of said frame to the tissuewall.
 6. The occluder of claim 2, wherein each of said frame structureshas fabric attached thereon, and wherein said fabric of each said framestructure is conjoined at a single location so as to define a centerfabric attachment point for said occluder.
 7. The occluder of claim 1,wherein said attachment between said two portions is provided by asingle fiber of material.
 8. The occluder of claim 7, wherein saidattachment between said two portions is provided by a single fiber ofwire material.
 9. The occluder of claim 1, wherein said attachmentbetween said two portions is provided by a plurality of fibers ofmaterial.
 10. The occluder of claim 9, wherein said plurality of fibersare constructed to define two loops.
 11. The occluder of claim 2,wherein said fabric comprises a polyester knit.
 12. The occluder ofclaim 11, wherein said knit comprises a 30 denier polyester knit.
 13. Areversibly deployable tissue opening occluder comprising an occluderpanel and an anchor assembly extending therefrom, said occluder panelcomprising a fabric support structure and fabric supported by aperimeter thereof, said anchor assembly comprising a planar wire anchorelement adapted to be selectively manipulatable in furtherance ofpositioning and securing said occluder panel at a tissue opening situs,said wire anchor element being at least indirectly linked to a centralportion of said fabric support structure, said occluder panel and saidanchor assembly being thereby opposingly urged into engagement with thetissue opening in furtherance of closure.
 14. The tissue openingoccluder of claim 13 wherein said anchor assembly further includes alinkage, said linkage joining said planar wire anchor element to saidoccluder panel.
 15. The tissue opening occluder of claim 14 wherein saidlinkage is capable of reversible elongation.
 16. The tissue openingoccluder of claim 15 wherein said linkage comprises a wire segment. 17.The tissue opening occluder of claim 15 wherein said linkage comprises awire structure.
 18. The tissue opening occluder of claim 15 wherein saidlinkage comprises at least a single loop.
 19. The tissue openingoccluder of claim 15 wherein said linkage comprises at least a singlespring element.
 20. The tissue opening occluder of claim 13 wherein saidanchor assembly further includes a linkage, said linkage interposedbetween said planar wire anchor element and said occluder panel.
 21. Thetissue opening occluder of claim 20 wherein said linkage is capable ofreversible elongation.
 22. The tissue opening occluder of claim 20wherein said linkage comprises a suture.
 23. The tissue opening occluderof claim 20 wherein said linkage comprises a wire.
 24. The tissueopening occluder of claim 20 wherein said linkage comprises a wirestructure.
 25. The tissue opening occluder of claim 20 wherein saidlinkage comprises at least a single loop.
 26. The tissue openingoccluder of claim 20 wherein said linkage comprises at least a singlespring element.
 27. The tissue opening occluder of claim 14 wherein saidfabric support structure includes at least a single eyelet.
 28. Thetissue opening occluder of claim 27 wherein said at least a singleeyelet comprises at least a single coil formed integral to said fabricsupport structure.
 29. The tissue opening occluder of claim 28 whereinsaid eyelets are circular.
 30. The tissue opening occluder of claim 28wherein said eyelets are elongate forms.
 31. The tissue opening occluderof claim 28 wherein said eyelets are angular forms.
 32. The tissueopening occluder of claim 27 wherein at least one of said at least asingle eyelet is located within said central portion of said fabricsupport structure
 33. The tissue opening occluder of claim 32 whereinsaid anchor assembly extends from said at least one of said at least asingle eyelet is located within said central portion of said fabricsupport structure.
 34. The tissue opening occluder of claim 33 whereinsaid planar wire anchor element includes at least a single eyelet. 35.The tissue opening occluder of claim 34 wherein the planar wire anchorelement eyelet is connected to the fabric support structure eyelet. 36.The tissue opening occluder of claim 35 wherein said wire anchor elementincludes at least a single tissue engaging hook.
 37. Apparatus foroccluding an opening in a tissue wall, comprising: an occluder portionadapted for interposition in the opening, said occluder portionincluding a frame defining a perimeter; a generally linearly extendinganchor carried by said occluder portion, said anchor having oppositeends extending beyond said perimeter to engage the tissue wall and fixsaid occluder portion in the opening.
 38. Apparatus of claim 37 whereinsaid anchor is integral with said frame.
 39. Apparatus of claim 38wherein said anchor and said frame are formed of nitinol.
 40. Apparatusof claim 37 wherein said occluder portion is formed of a knit polyester.41. A method of occluding an opening in a tissue wall, comprising thesteps of: collapsing an occluder assembly in a deployment catheter;positioning the catheter proximate the tissue wall to deploy a firstportion of the occluder assembly with a frame of the first portion inengagement with one side of the tissue wall; and maneuvering thecatheter to deploy a second portion of the occluder assembly with aframe of the second portion in engagement with an opposite side of thetissue wall and discrete points, one on each of the portions of theoccluder assembly, interlinked through the opening in the tissue wall.42. A method of occluding an opening in a tissue wall, comprising thesteps of: collapsing an occluder assembly in a deployment catheter;positioning the catheter proximate the tissue wall to deploy a firstportion of the occluder assembly with a frame of the first portion inengagement with one side of the tissue wall; and maneuvering thecatheter to deploy a wire frame anchor in engagement with an oppositeside of the tissue wall, a discrete point on the first portion of theoccluder assembly interlinked, through the opening in the tissue wall,with a discrete point on the wire frame anchor.
 43. A method ofoccluding an opening in a tissue wall, comprising the steps of:collapsing an occluder assembly in a deployment catheter, the occluderassembly including an occluder portion, having a frame, adapted forinterposition in the opening, and a generally linearly extending anchorcarried by said occluder portion, said anchor having opposite endsextending beyond said perimeter to engage the tissue wall; positioningthe catheter proximate the tissue wall; and deploying the occluderassembly into the opening, wherein the ends of the anchor extendingbeyond the perimeter to engage the tissue wall and fix said occluderassembly in the opening.